Director Regulatory & Clinical Affairs

Director of Regulatory Affairs

Metric Bio is looking for an experienced Regulatory Affairs leader to develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML-based medical software.

• Develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML-based medical software.
• Lead U.S. FDA submissions including 510(k), De Novo, PMA, Q‑Sub meetings, responses, amendments, and technical documentation.
• Prepare regulatory documentation, including design dossiers, device master files, labeling, clinical evaluation reports (CERs), and risk management files.
• Serve as the primary liaison with the U.S. FDA and participate in pre‑submission meetings, inspections, and audits.
• Oversee global regulatory preparation and submissions (EU MDR/IVDR, Canada, Australia, APAC as applicable).

• Develop and execute clinical strategies for U.S. and global product validation.
• Oversee clinical study design, IRB submissions, site selection, investigator management, CRO coordination, enrollment tracking, and study governance.
• Lead clinical data collection, clinical evaluation reports, safety assessments, and post‑market clinical follow‑up activities.
• Ensure compliance with Good Clinical Practice (GCP), clinical regulations, and applicable global standards.

• Ensure adherence to ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA QSR (21 CFR 820), and SaMD guidance.
• Provide regulatory input to product development, risk analysis, labeling, market claims, and change management.
• Support Quality Assurance activities, including inspection readiness, CAPA, internal audits, and regulatory documentation.
• Collaborate closely with R&D, Quality, Product Management, and Operations teams across global locations.

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field (Master’s preferred).
• 8–10 years of experience in U.S. medical device or diagnostics regulatory affairs and clinical affairs.
• Experience with digital pathology, imaging systems, diagnostics, or Software as a Medical Device (SaMD).
• Strong understanding of global regulatory frameworks, including EU MDR/IVDR, Health Canada, and TGA.
• Demonstrated leadership experience managing regulatory teams or complex cross‑functional initiatives.

• RAC (Regulatory Affairs Certification).
• Experience with AI/ML‑enabled diagnostic products.
• Experience leading global, multi‑site clinical trials.
• Knowledge of cloud‑based digital diagnostic platforms.

• Director

• Full‑time

• Other

• Hospitals and Health Care

Location:

San Jose, CA